Kornimate/medical-research-clean huggingface dataset:
characteristics of eye diseases in children and adolescents with autism spectrum disorders and the effect of corresponding treatment on the quality of life of children and adolescents with autism and their caregivers

Conditions: Autism Spectrum Disorder; Visual Function

Summary: this study mainly investigated the incidence of eye diseases in children with autism spectrum disorder(asd) in tianjin area, and analyzed related risk factors, so as to raise attention to eye diseases in children with asd. to evaluate the impact of ophthalmic treatment on the quality of life of children with autism and their primary caregivers.

in recent years, the incidence of autism has increased year by year, which has brought a heavy burden to society and families. for the special group of children with autism spectrum disorder, previous studies focused on the lack of comprehensive and accurate visual function characteristics and defects of this group. in the early stage, it was believed that there was a certain correlation between visual impairment and autism, and some patients with visual impairment were misdiagnosed as autism. moreover, some studies have shown that the incidence of refractive errors and oblique amblyopia in autistic children is significantly higher than that in normal children. this study mainly includes two parts: on the one hand, investigate the autism children in tianjin area to understand the incidence of eye diseases. on the other hand, children with eye problems were given relevant interventions, such as optometry, amblyopia training, strabismus surgery, etc., to assess the impact of the corresponding treatment on the quality of life of the children and their primary caregivers.

Eligibility criteria:
inclusion criteria: * patients diagnosed with asd but without medical intervention. to cooperate with relevant inspectors. exclusion criteria: * brain organic diseases (such as tumors, strokes, epilepsy, etc.) and serious physical diseases (such as heart, liver, kidney and other organ dysfunction, cancer, etc.);do not cooperate to check.
a study of glutamine to treat intestinal permeability in functional dyspepsia

Conditions: Functional Dyspepsia

Summary: the purpose of this research is to collect data from patients diagnosed with functional dyspepsia who are treated with glutamine and describe safety and treatment results compared to patients taking a placebo. glutamine, an essential amino acid in humans, is an important energy source for cells lining the gastrointestinal tract and has been shown to play an important role in regulating the strength of the intestinal wall.


Eligibility criteria:
inclusion criteria: * meet rome iv criteria for functional dyspepsia (https://theromefoundation.org/rome-iv/rome-iv-criteria/) * patients will generally be in good health. during initial evaluation, patients' symptoms will be assessed and patients categorized into either the pds, eps or mixed subtype of fd. exclusion criteria: * significant comorbid illness * symptoms are thought to represent an organic disorder (e.g., peptic ulcer disease, hepatitis, pancreatitis, inflammatory bowel disease, type i diabetes, a known malignancy, radiation-induced injury, an active infection, vasculitis, celiac disease), or if the patients have known esophagitis, eosinophilic esophagitis or h. pylori. * prior surgery to the esophagus, stomach or duodenum will be excluded, as will those taking proton pump inhibitors (ppis), opioids, corticosteroids and those taking regular (daily) antihistamines, non-steroidal anti-inflammatory drugs (nsaids), or mast-cell stabilizing agents within the prior 2 weeks. of note, patients taking ppis will be given the opportunity to discontinue their ppi in favor of famotidine 20 mg daily for 2 weeks before enrollment. * known allergies to lactulose: mannitol. * active tobacco use and excessive alcohol use (defined as 8 or more drinks per week for women or 15 or more drinks per week for men; http://ww.cdc.gov) * co-existing ibs will be allowed to enter the study as long as symptoms are not predominant. * hepatic and renal impairment within the past 6 months. defined as ast/alt \> 2x uln, total bilirubin \> 2 x uln, estimated glomerular filtration rate (egfr) of \< 60 ml/min/bsa. * diagnosed with galactosemia. * pregnant or breastfeeding women. * patients with documented or reported lactose intolerance.
alcohol use and sexual risk: an intervention

Conditions: Sexual Risk Behavior; Alcohol Use; Drug Use

Summary: adolescents are at great risk for sexually transmitted diseases (stds) including the human immunodeficiency virus (hiv) (cdc, 2000a; dilorenzo \& whaley, 1999). though the cdc (2000b) reports that overall aids incidence is on the decline, there has been no comparable decline in the number of newly diagnosed hiv cases among young people aged 13-19, and young people of color are particularly at risk. compared to the general adolescent population, adolescents involved with the criminal justice system are younger at first intercourse, have a greater number of sex partners, and lower rates of condom use, resulting in higher rates of unintended pregnancy and stds (e.g., st. lawrence et al., 1999). alcohol use is commonly cited as a reason for lack of condom use among high-risk adolescents such as those involved in the criminal justice system (e.g., morris et al., 1998) and recent data from our research suggests that it is heavy alcohol use in concert with sexual activity that is most strongly related to lack of condom use (bryan, rocheleau, \& robbins, 2002a). the goal of this research is to design, implement, evaluation, and disseminate a successful hiv/std risk reduction intervention that is theory-based, empirically targeted to adolescents, and articulated to a criminal justice setting. the study compares a sexual risk reduction intervention with a group motivational interviewing alcohol component to a standard sexual risk reduction intervention and a no treatment control condition. the investigators hope to show that: 1) a three-hour one-time intervention has the capacity to reduce sexual risk behavior up to one year post-release among high risk adolescents in detention, 2) a combined sexual and alcohol risk reduction intervention will result in larger decreases in sexual risk behavior than a sexual risk reduction alone, 3) the interventions will exert their effects through changes in mediators derived from a theoretically-based model of condom use intentions and behaviors, and 4) a sexual risk reduction intervention including an alcohol component will be especially effective for those adolescents with higher levels of existing alcohol problems. finally, given proven efficacy, the intervention curricula and materials will be disseminated for use in adolescent detention facilities throughout the state.


Eligibility criteria:
inclusion criteria: * all young people between the ages of 14 and 17 who were in the detention centers at which recruitment took place. exclusion criteria: * age less than 14 or non-english speaking

Keywords: sexual risk behavior among adolescents alcohol and drug use among adolescents
natural berry extract treatment of hemangiomas

Conditions: Hemangioma

Summary: this is a prospective, randomized, double-blind, placebo-controlled parallel group study evaluating the use of pediaberry for the treatment of hemangiomas in infants ≤ 4 months of corrected gestation age over a 6-month treatment period. subjects will be followed to age 18 months. a total of 44 subjects will be pediaberry group and 22 subjects in the placebo control group.

pediaberry™ is a proprietary blend of powdered berry extracts. placebo: powdered sugar plus mccormick color from nature food colors berry and sky blue powdered food color (https://www.mccormick.com/spices-and-flavors/extracts-and-food-colors/food-colors/color-from-nature-assorted-food-color ). cream vehicle is mixed with pediaberry™ or placebo at the time of application.children will receive once daily topical and oral gavage dosing of pediaberry or placebo. the first study visit will take place within 2 weeks of subject recruitment. the subject enrollment, consenting and randomization will occur as study visit #0 and will occur at riley children's hospital or nationwide children's hospital. data collection will be the same at all study visits starting with study visit #1 until the completion of the study. the first dose of pediaberry™ or placebo will be administered prior to completion of study visit #1, and will also be given at study visits #2-6. study visits #2-6 will occur monthly study visits until the subject completes 6 months of treatment.subjects will be weighed and treatment doses adjusted accordingly. study visits #7-11 to watch for signs of rebound hemangioma proliferation will occur every other month until age 12 months and then at age 15 and 18 months. urine samples, photos and caliper measurements will occur at each study visit. some subjects may have less than 11 study visits depending on the age at the time of subject enrollment.

Eligibility criteria:
inclusion criteria: * children with hemangiomas ≤ 4 months and 2 weeks of corrected gestational age * hemangioma size ≥ 1 cm diameter exclusion criteria: * children with hemangiomas that threaten the life of the child or development of vital structures. * children who are breast feeding and mother is taking beta blocker medication * children with previously treated hemangiomas * congenital hemangiomas - cannot distinguish between rapidly involuting and non-involuting congenital hemangiomas * hemangiomas located in the perineal/diapering area - product will get contaminated or wiped off with diapering * children with food allergies to blueberries or any other kind of berry * legal guardian unable to provide informed consent

Keywords: mir126 pediaberry
effects of lowering dialysate calcium level on progression of coronary artery calcification and bone histomorphometry

Conditions: End-Stage Renal Disease; Hemodialysis

Summary: the high rate of cardiovascular complications in the dialysis population cannot be explained by traditional cardiovascular risk factors. one of such factors proposed to contribute to the cardiovascular mortality in dialysis patient population is vascular calcification possibly resulting from disturbances of calcium-phosphate metabolism. the aim of this study is to assess the effects of treatment with dialysate containing 1.75 or 1.5 mmol/l to 1.25 mmol/l calcium regarding coronary artery calcification and bone histomorphometry in hemodialysis patients.

sample size calculations were based on previously reported changes in coronary artery calcification scores in hemodialysis patients during time (90% power with a two-sided, alpha error rate of 5%). four hundred fifty-seven hemodialysis patients, taking drop-out rate into consideration, will be enrolled in this prospective-controlled study.the cases already being treated with calcium-based phosphate binder and dialysate containing 1.75 or 1.5 mmol/l calcium will be enrolled from eight hemodialysis centers.the cases will be randomized to two arms: 1. dialysate containing 1.25 mmol/l calcium + calcium-based phosphate binder group: dialysate calcium will be reduced from 1.75 or 1.5 mmol/l to 1.25 mmol/l in this group. patients will use calcium-based phosphate binder according to phosphate level. 2. dialysate containing 1.75 mmol/l calcium + calcium-based phosphate binder group (control group): dialysate calcium will remain or switched to 1.75 mmol/l and patients will be on calcium-based phosphate binder. the study will last for 18 months.coronary artery calcification (multi-slice ct), bone histomorphometry, and bone mineral density will be assessed in the beginning and at the end of the study. coronary artery calcification and bone mineral density will be measured in all patients; bone histomorphometry will be assessed in 150 patients, 75 from each group.

Eligibility criteria:
inclusion criteria: * aged between 18 and 80 years * on maintenance bicarbonate hemodialysis scheduled thrice weekly, at least 12 hours/week * to be treated with a dialysate containing 1.75 or 1.5 mmol/l calcium * willingness to participate in the study with a written informed consent exclusion criteria: * to be scheduled for living donor renal transplantation * to have serious life-limiting co-morbid situations, namely active malignancy, active infection, end-stage cardiac, pulmonary, or hepatic disease * pregnancy or lactating * to be unable to give informed consent because of mental incompetence or a psychiatric disorder * to be on vitamin d treatment within six months of randomization or having ipth values over target levels (\>300 pg/ml) * hypercalcemia (ca \>10.5 mg/dl) with use of dialysate containing 1.75 or 1.5 mmol/l calcium

Keywords: hemodialysis coronary artery calcification adynamic bone disease dialysate calcium bone mineral density bone histomorphometry
interstitial lung disease: a study from infancy to elderly including relatives

Conditions: Interstitial Lung Diseases

Summary: the concerned patients are children and adults suffering from idiopathic interstitial pneumonias, other chronic fibrosing interstitial pneumonias with a progressive phenotype, and interstitial pneumonia associated with scleroderma and related cases of patients carrying a mutation on one of the telomere-associated genes. this is a national, observational, longitudinal, multicenter study that will be conducted retrospectively and prospectively. it aims to collect consistent and comparable clinical data for patients and their relatives, whether they carry a mutation or not, affected by diffuse idiopathic interstitial pneumopathy. the expected duration of the study, including data analysis, is approximately 10 years (5 years for participant enrollment and 5 years of follow-up, in addition to the steps for data management and statistical analyses). each participating center will inform every participant by providing an information sheet, and their written consent will be obtained before including them in the study and commencing data collection. prospective medical data will be collected at 6 months to 1 year after enrollment and then at least once per year for patients up to 5 years and 5 years for their relatives. participants will complete a self-questionnaire during their regular follow-up consultations or by accessing a secure interface.


Eligibility criteria:
inclusion criteria: confirmed diagnosis of iip established based on clinical, radiological, or functional criteria. confirmed diagnosis of non-ipf progressive fibrotic interstitial lung disease (pf-ild) with fibrosis ≥ 10% on ct scan, disease worsening not related to pulmonary embolism, decompensated heart failure, or lower respiratory tract infection, and disease progression despite "appropriate management" evaluated over a period of up to 24 months: * a relative decline in forced vital capacity (fvc) of at least 10% from predicted value, with or without clinical deterioration, or * a combination of at least 2 of the following criteria: a relative decline in fvc between 5% and 10% from predicted value, worsening respiratory symptoms, increased extent of pulmonary fibrosis on thoracic ct scan. confirmed diagnosis of systemic sclerosis-associated interstitial lung disease (ssc-ild) (american college of rheumatology criteria), with a total score ≥ 9 and disease extent involving ≥ 10% of the lungs (defined by reticular abnormalities, honeycombing, and ground-glass opacities) on high-resolution ct (hrct) scan. for relatives: first degree relatives of patients carrying a mutation in tert, terc, rtel1, tinf2, dkc1, parn genes, and other telomere related genes that may be described in the future and included.

Keywords: pediatric interstitial lung diseases idiopathic pulmonary fibrosis pediatrics / adult idiopathic interstitial pneumonia
safety and efficacy study of lipo-202 for the reduction of central abdominal bulging in obese subjects

Conditions: Central Abdominal Bulging

Summary: this is a multi-center, randomized, placebo-controlled, double-blind study evaluating the safety and efficacy of lipo-202 for the reduction of central abdominal bulging in obese subjects.


Eligibility criteria:
inclusion criteria: * healthy male or non-pregnant female subjects * capable of providing written consent * bmi \> 30 kg/m2 but \< 40 kg/m2 * stable diet and exercise routine * at least "slightly dissatisfied" with their abdominal bulging on the abdominal contour questionnaire (acq) exclusion criteria: * bmi \> 40 kg/m2 * have had any treatment of the fat around your abdomen, including surgical procedures (tummy tuck, liposuction), injections for fat loss or treatments with devices to reduce fat in your abdomen. * plan on starting a weight loss or exercise program during the study * known hypersensitivity to study drugs * have any medical condition that might complicate study procedures
polish bifurcation optimal treatment strategy study for left main bifurcation percutaneous coronary intervention (pci)

Conditions: Coronary Stenosis

Summary: the primary objective of this study is to study the safety and efficacy of the bioss lim c with respect to patient oriented composite endpoint (poce) at 12 months in a "real world" left-main bifurcation population and as compared with a prespecified performance goal.


Eligibility criteria:
inclusion criteria: * patient has distal unprotected left-main coronary artery (ulmca) disease with angiographic diameter stenosis (ds) ≥50% requiring revascularization. * left-main medina classification 100, 110, 101, 011, 010, 111 * clinical and anatomic eligibility for pci as agreed by the local heart team including anatomic syntax score (\<33). * distal left main reference vessel diameter ≥3.0 mm and ≤5.5 mm. all target lesions must be located in a native coronary artery. * patient with silent ischemia, chronic stable angina or stabilized acute coronary syndromes with normal cardiac biomarker values * able to understand and provide informed consent and comply with all study procedures including follow-up exclusion criteria: * prior pci of the left main bifurcation at any time prior to enrollment * currently participating in another trial and not yet at its primary endpoint. * prior pci of any other (non left main bifurcation) coronary artery lesion within 6 months (\<6 months) prior to enrollment. * left-main medina classification 001. * any segment of the left main bifurcation (distal left main, ostial left anterior descending artery (lad) or ostial left circumflex artery (lcx) presenting with a chronic total occlusion, or containing a visible thrombus. * excessive angulation of the left main bifurcation (i.e. an angulation \>90° between proximal lad and proximal lcx) * direct stenting of the left main bifurcation * prior coronary artery bypass surgery (cabg) at any time prior to enrollment * patient requiring or may require additional surgery (cardiac or non-cardiac) within one year * ongoing myocardial infarction or recent myocardial infarction with cardiac biomarker levels still elevated. * known renal insufficiency (e.g. serum creatinine \>2.5mg/dl, or creatinine clearance ≤30ml/min, or patient on dialysis). * known contraindication or hypersensitivity to sirolimus, everolimus, cobalt-chromium, or to medications such as aspirin, heparin, bivalirudin, and all of the following four medications: clopidogrel bisulfate, ticlopidine, prasugrel, ticagrelor. * patients unable to tolerate, obtain or comply with dual antiplatelet therapy for at least 12 months. * patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential). * concurrent medical condition with a life expectancy of less than 12 months. * the patient is unwilling/not able to return for outpatient clinic at 12 month follow-up. * currently participating in another trial and not yet at its primary endpoint.

Keywords: coronary artery disease (cad) percutaneous coronary intervention (pci) left main bifurcation
study to evaluate concordance of detecting egfr (epidermal growth factor receptor) mutation by circulating tumour free dna versus tissues biopsy in nsclc (non-small cell lung cancer).

Conditions: NSCLC (Non-small Cell Lung Cancer)

Summary: this is a multicentre, prospective, study of egfr )epidermal growth factor receptor) mutation status in advanced nsclc (non-small cell lung cancer)patients (locally advanced and/or metastatic disease) with adenocarcinoma histology proposed to be conducted at 15 sites from different geographical regions across india. the study targets to enrol 268 patients over a period of 6 months.

this is a multicentre, prospective, study of egfr mutation status in advanced nsclc patients (locally advanced and/or metastatic disease) with adenocarcinoma histology proposed to be conducted at 15 sites from different geographical regions across india. the study targets to enrol 268 patients over a period of 6 months. the study will enroll patients with histologically confirmed, systemic treatment naïve adenocarcinoma metastatic cancer (stage iv). this will be a single visit study. no study medication will be prescribed or administered as a part of study procedure.

Eligibility criteria:
inclusion criteria: 1. patients who provide written informed consent 2. patients aged 18 years and older 3. newly diagnosed patients with metastatic (stage iv) nsclc. 4. histologically confirmed adenocarcinoma nsclc patient as per tissue biopsy and tissue sample sent for egfr mutation analysis or result for egfr mutation test is available from last 28 days from the date of enrolment. 5. patient should be naïve for any systemic treatment (i.e. no chemotherapy or egfr-tki) exclusion criteria: 1. patient with any medical condition that, in the opinion of the investigator, would interfere with outcome of the study 2. patient participating in any other interventional clinical study/trial.

Keywords: epidermal growth factor receptor
a repeated dose study of khk6640 in japanese patients with alzheimer's disease

Conditions: Alzheimer Disease

Summary: the purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of khk6640, given as a repeated dose in japanese patients with mild to moderate alzheimer's disease.


Eligibility criteria:
inclusion criteria: * patients with mild to moderate alzheimer's disease * body weight ≥ 40 kg and \< 100 kg * clinical dementia rating (cdr) score of 1 or 2 * mini mental state examination (mmse) score of ≥ 17 amd ≤ 26 exclusion criteria: * previous active treatment with an alzheimer's disease immunotherapy in an investigational study * use of another investigational drug within 16 weeks prior to the enrollment * subjects who meet national institute of neurological disorders and stroke/association internationale pour la recherche et l'enseignement en neurosciences (ninds/airen) criteria for vascular dementia * subjects with a history of presence of clinically significant seizures, brain trauma, transient ischemic attack, and/or cerebrovascular disease * subjects with a presence of a neurological condition that could be contributing to cognitive impairment above and beyond that caused by the subject's alzheimer's disease * subjects who have evidence of infection, tumor, or other clinically significant lesions that could indicate a dementia diagnosis other than alzheimer's disease